FDA Enforcement and Recall Report Week of May 16

Each week the FDA reports on its enforcement activities. To help capture and digest that information the FDA Atty blog will post FDA recalls and warning letters.

FDA Recalls

Anyone subscribing to the FDA recall e-mail list received saw only a small slow down in the barrage of FDA food recall notices related to the frozen food recall. This past week the recall notices continued as part of the frozen food recall connected to CRF Foods. A total of 28 recall notices posted – that is only a reduction of 7 notices compared to last week.

Typically FDA food recall notices involve undeclared allergens. This has been the case the past three weeks. A Listeria outbreak linked to CRF Foods impacting 358 products across 42 brands. The Listeria recalls constituted a full 64% of the recall notices (18 of the 28).

Undeclared allergens came in second with 4 of the 28 (a very small number compared to most weeks), four other pathogen recalls, a quality control recall due to over salting and a  hazard recall and one Sildenafil recall in a dietary supplement rounded out the list.

A busy week demonstrating how interconnected the food supply chain can be. One key feature of FSMA is supplier verification and integration of the supply chain. A recall notice like CRF Foods highlights why supplier verification became a key component of FSMA.

The frozen food recall will likely contninue to generate notices for the next week or two.

FDA Warning Letters

FDA Warning Letters post weekly but generally are issued earlier than posted. The most recent FDA Warning Letters involve no letters from  center for tobacco  for Family Smoking Prevention violations. This is unusual compared to most weeks.

A full five (5) letters were issued for Good Manufacturing Practice (GMP or cGMP) issues. A week like this emphasizes how GMP issues are not confined to the FDA Form 483.

Similar to last week one warning letter was issued for claims leading to reclassification as a new drug. This week a warning letter designated several products as new drugs for express and implied disease claims.  Also interest to note a warning letter last week due to Sildenafil or analogs of Sidenafil. This connects with the recall from a separate company also related to Sildenafil. This is a common issue with dietary supplements, in particular male enhancement supplements.

Please contact our Washington D.C. or Charlotte NC office with any FDA recall, Warning Letter or other enforcement questions.

FDA Recalls May 6 – May 13

05/13/2016 Fresh Attractions, 1897, Ciao, Farmers Market, more Trail Mix Listeria monocytogenes HMSHost
05/13/2016 Hy-Vee Fried Rice Listeria monocytogenes Hy-Vee, Inc.
05/13/2016 The Farmers Market Chopped Asian Salad Kit Undeclared Almonds, Soy and Wheat Fresh Express
05/13/2016 Productos Del Campo Castillo Habanero Peppers Salmonella Montero Farms
05/12/2016 Piggly Wiggly Yellow Cut Corn Listeria monocytogenes, CRF2016 McCall Farms Inc.
05/11/2016 Whole Foods Market Korean BBQ Sauce Undeclared peanuts and tree nuts (coconut) Whole Foods Market
05/11/2016 Vending Nut Company Sunflower kernel products Listeria monocytogenes Vending Nut Company
05/10/2016 Nature’s Promise, Woodstock, Market Basket, Woodfield Farms Walnuts and walnut-containing products Listeria monocytogenes United Natural Trading LLC dba Woodstock Farms Manufacturing
05/10/2016 Frontier Co-op Organic Hojicha Tea Salmonella Frontier Co-op
05/10/2016 Trader Joe’s Kale & Edamame Salad Salmonella WCD Kitchen, LLC
05/10/2016 Simple Truth Organic mixed vegetables Listeria monocytogenes, CRF2016 The Kroger Co.
05/10/2016 Publix Cranberry nut and seed mix Listeria monocytogenes Publix Super Markets
05/10/2016 Tiger-X, Ninja-X, Ginseng Power-X, Super Samurai-X Marketed as a dietary supplement Products contain Sildenafil, and analogs of Sildenafil SOS Telecom, Inc.
05/09/2016 Natural Directions Organic Mixed Vegetables and Organic Green Peas Listeria monocytogenes, CRF2016 NORPAC Foods, Inc.
05/09/2016 Uncle Bucks Sweet & Salty Trail Mix Listeria monocytogenes Rucker’s Wholesale and Service Co.
05/09/2016 Let’s Talk Health “Energizer Drink Mix,” Agua Vitae Liquid Multi-Vitamin, Agua Vitae Kids Liquid Multi-Vitamin and Tox-Elim Undeclared milk and soy Let’s Talk Health, Inc.
05/09/2016 Kroger Broccoli Raisin Salad Listeria monocytogenes The Kroger Co.
05/09/2016 Pictsweet Frozen Vegetables Listeria monocytogenes, CRF2016 The Pictsweet Company
05/09/2016 Dollywood Sweet & Salty Trail Mix Listeria monocytogenes Rucker’s Makin’ Batch Candies, Inc.
05/07/2016 Tai Pei, Trader Joe’s, Hy-Vee, more Frozen foods Listeria monocytogenes, CRF2016 Ajinomoto Windsor, Inc.
05/07/2016 Kroger, P$$T Frozen Vegetables Listeria monocytogenes, CRF2016 The Pictsweet Company
05/06/2016 Central Market Organic, HEB, Sweetfrost and Woodstock Vegetable Products Containing Organic Peas Listeria monocytogenes, CRF2016 Twin City Foods, Inc
05/06/2016 Pulmuone Korean Noodles Undeclared Milk Pulmuone Foods USA
05/06/2016 Watts Brothers Farms, Trader Joe’s Frozen vegetable products Listeria monocytogenes, CRF2016 ConAgra Foods
05/06/2016 Harris Teeter Frozen Organic Corn and Frozen Mixed Vegetables Listeria monocytogenes, CRF2016 Harris Teeter
05/06/2016 Stahlbush IQF Green Beans Listeria monocytogenes Stahlbush Island Farms, Inc.
05/06/2016 Manna Pro Chick Starter Medicated May contain excessive salt Manna Pro Products, LLC
05/06/2016 Dorothy Lynch Home Style Dressing Dorothy Lynch Home Style Dressing Bacteria (lactobacillus) Tasty Toppings, Inc.0

FDA Warning Letters as of 5/16/16

May 04, 2016 Corey Kay Kansas City District Office Illegal Drug Residue Not Issued *
May 02, 2016 Summit Beverage Group, LLC Baltimore District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 29, 2016 PharmaLogic CSP, Inc. Baltimore District Office CGMP/Compounded Drugs/Misbranding Not Issued *
April 28, 2016 Macular Health New Orleans District Office New Drug/Misbranded Not Issued *
April 27, 2016 Riddhi USA Inc. New York District Office CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated Not Issued *
April 27, 2016 Service First Pharmacies Inc, dba Madison Drugs New Orleans District Office CGMP/Compounded Drugs/Misbranding Not Issued *
April 26, 2016 S & S Foods, Inc. Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
April 25, 2016 Faye’s Texas Naturals Dallas District Office Acidified Foods/Emergency Permit Control/Adulterated Not Issued *
April 21, 2016 Hartley Medical Center Pharmacy, Incorporated Los Angeles District Office CGMP/Compounded Drugs/Misbranding Not Issued *
Apotheca Supply, Inc 04/07/2016 New Orleans District Office CGMP/Active Pharmaceutical Ingredient (API)/Adulterated No
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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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